Using ctDNA to guide chemotherapy for elderly colon cancer patients after surgery
ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study
This study tests if using a blood test to check for cancer DNA can help doctors decide the best chemotherapy for older patients with high-risk colon cancer after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 70 Years to 80 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06609551 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of ctDNA detection in guiding adjuvant chemotherapy regimens for elderly patients with high-risk stage II and III colon cancer. Participants will undergo ctDNA testing post-surgery to assess their disease status and will be monitored for disease-free survival. Based on ctDNA results, patients will be randomized to receive either observation or specific chemotherapy treatments. The study aims to correlate ctDNA status with imaging results and patient prognosis.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 70-80 with histopathologically confirmed high-risk stage II or stage III colon cancer.
Not a fit: Patients with severe concomitant systemic diseases or a history of malignant tumors within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective chemotherapy regimens for elderly colon cancer patients, potentially improving their disease-free survival rates.
How similar studies have performed: While the use of ctDNA in cancer management is gaining traction, this specific approach in elderly colon cancer patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 70-80, both male and female are eligible; 2. Patients with histopathologically confirmed stage II high-risk or stage III colon cancer; 3. Patients with an ECOG score of ≤2; 4. Patients who are required to undergo tissue genetic testing; 5. Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits. Exclusion Criteria: 1. Patients with one or more severe concomitant systemic diseases that, in the investigator\'s opinion, would impair the patient\'s ability to complete the study. 2. Patients who have had a history of malignant tumors within 5 years. 3. Any unstable systemic disease (including active infection, poorly controlled diabetes, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction within one year, severe arrhythmia requiring medical treatment, liver, kidney, or metabolic diseases). 4. Patients suffering from severe mental illnesses. 5. Patients who have participated in other clinical trials within 30 days prior to screening. 6. Patients who are unable to undergo adjuvant chemotherapy.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yuping Zhu, M.D.
- Email: drzyp@163.com
- Phone: 86-0571-88128011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.